Tuesday, January 26, 2016

Clinical trial of painkiller killed volunteer in France

In France, some people died during a clinical trial of a newly drug.

The subject being examined is a cannabis-based painkiller. One person who participated in the trial as a volunteer became the status of brain dead, to be fatal after a while. Five other participants are in a critical condition.

Clinical trials are usually deliberately designed. Before the approval for clinical use, there are three hurdles for the drug to overcome. In Phase 1, healthy volunteers are to take the drug with continuous observation. In Phase 2, patients who require the solution of the candidate drug are subjected. The purpose of this phase is to identify the optimal dose of the drug for clinical benefit. In Phase 3, a larger number of patients are to take part in the trial, to confirm the effectiveness and safety of the drug. A randomized clinical trial is usually conducted. After the all phases are finished, the authority approves the clinical use of the new drug.

These accidents occurred in Phase 1. Thus, the victims were healthy before the trial. It means that the fatality was attributable to the drug itself, not to the participants.

All substance has a certain risk for the human body potentially. However, there were only 90 people having taken the drug when the fatal case occurred. The probability of an adverse event was too big to be interpreted as by chance.

Of course, this clinical trial had been approved by the authority. However, some researchers are voicing that the design of this trial can be wrong. They claimed that if successive prescription to the next participant had been delayed, as regulated in advance by the protocol, these tragic events would have been prevented, even if the first critical case could not be avoided.

It is no doubt that adequate interval should be equipped between starting the prescription. On the other hand, Drug companies have no time to spend in drug development due to inter-company competition and restrictive budget. It is required to reconsider the standard of implementing a clinical trial with scientific evidence and feasibility.

I am very sorry for the victims of this trial. I have to recognize that today’s medical science is established on enormous errors and failures.